Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Christopher Strouse
Study ID
NCT07581704
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sirolimus — DRUG
    Sirolimus is an immunosuppressant drug. Sirolimus binds to FK binding protein 12 and inhibits mTOR. This then suppresses T-cell proliferation and inhibits progression from G1 to S phase of the cell cycle.
  • Teclistamab — BIOLOGICAL
    Teclistamab is a bispecific antibody that binds the CD3 receptor on T-cells and the B-cell maturation antigen on multiple myeloma cells and healthy B-lineage cells.
  • Talquetamb — BIOLOGICAL
    Talquetamab is a bispecific antibody that binds the CD3 receptor on T-cells and the GPRC5d receptor on multiple myeloma cells.

Study Details

This is a single center, single arm Phase Ib study with expansion cohort designed to establish the safety and physiologic effects of sirolimus pre-conditioning followed by T-cell engaging bispecific antibody therapy.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sirolimus in combination with teclistamab or talquetamab
    This study is designed to test changes in immune cell populations of patients with multiple myeloma exposed to short pre-conditioning with sirolimus prior to teclistamab or talquetamab. Safety of the combination will also be assessed.

Primary Outcome Measure

Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: From treatment initiation through 30 days post last dose of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Christopher Strouse, MD
[email protected]
319-356-0489
Christopher Strouse, MD
[email protected]
(319) 356-0489

Find similar trials in Iowa City, IA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Iowa Health Care· Iowa City, IA

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